NDC product

Neomycin and Polymyxin B sulfates and Hydrocortisone OTIC

NDC 0054-0975 · Hikma Pharmaceuticals USA Inc.

Key facts

Product NDC 0054-0975
Proprietary name Neomycin and Polymyxin B sulfates and Hydrocortisone
Nonproprietary name Neomycin and Polymyxin B sulfates and Hydrocortisone
Substances NEOMYCIN SULFATE, POLYMYXIN B SULFATE, HYDROCORTISONE
Dosage form SOLUTION/ DROPS
Route AURICULAR (OTIC)
Labeler Hikma Pharmaceuticals USA Inc.
Product type HUMAN PRESCRIPTION DRUG
Marketing category ANDA
Application number ANDA220938
Pharmacologic classes Aminoglycoside Antibacterial [EPC], Aminoglycosides [CS], Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC], Polymyxin-class Antibacterial [EPC], Polymyxins [CS]
Marketing start Oct 8, 2026
Listing certified through Dec 31, 2027

At a glance

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The National Drug Code (NDC) is the FDA's product identifier for drugs; the product NDC identifies the labeler and product, and each package adds a package code.

Source: U.S. Food and Drug Administration (FDA), National Drug Code Directory · Source date:

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